Foresee Pharmaceuticals begins FP-025 phase 2/3 trial in Covid-19 associated ARDS

Foresee Pharmaceuticals has started patient dosing in a phase 2/3 trial of FP-025 in adults having severe to critical Covid-19 with associated acute respiratory distress syndrome (ARDS).

According to the Taiwanese pharma company, FP-025 is an oral small molecule inhibitor of MMP-12, whose main functions are the modulation of various components such as elastin and collagen of the extracellular matrix.

Dr. Ben Chien – founder and Chairman of Foresee Pharmaceuticals said: “We are pleased to begin this Phase 2/3 study of FP-025. FP-025 showed significant therapeutic efficacy in preclinical inflammation and fibrosis models of the lung, suggesting that FP-025 may potentially avert the lung injury and fibrosis caused by COVID–19 infections.

“We look forward to evaluating the potential of FP-025 in the fight against the pandemic.”

The phase 2/3 clinical trial of FP-025 is a double-blind, placebo-controlled study for assessing its efficacy and safety in randomly grouped patients with severe to critical Covid-19 with associated acute respiratory distress syndrome, totaling around 99.

The phase 2 part of the clinical trial will be carried out in the US.

The patients will be grouped in a 1:1:1 ratio for getting FP-025 100mg, FP-025 300mg, or placebo daily two times for 28 days. The primary outcome measures of the mid-stage trial include the proportion of patients who have survived and do not need non-invasive or invasive ventilation at Day 28.

Foresee Pharmaceuticals plans to have an interim analysis at the end of the phase 2 trial, of which the efficacy results are anticipated to be out in Q4 2021.

Depending on the primary analysis results from the phase 2 study, an optimal dose will be picked to carry into phase 3 of the trial, where nearly 300 patients will be randomized in a 1:1 ratio to get either FP–025 or placebo for a period of 28 days.